Sahpra warns of counterfeit diabetes drugs in South Africa

SOUTH AFRICA—The South African Health Products Regulatory Authority (Sahpra) has raised an alert over the growing presence of counterfeit diabetes treatments, particularly Glucagon-like Peptide-1 (GLP-1) products like Ozempic, which have started to infiltrate the South African market.

These counterfeit versions of GLP-1-containing medications, designed to manage blood sugar levels and support weight loss, are reportedly being sold online, on social media, and through other unregulated channels.

Sahpra has cautioned the public against buying or using these unofficial products, emphasizing that their safety, effectiveness, and quality have not been evaluated.

 “Such products pose a serious health risk,” warned Sahpra, urging consumers to avoid them altogether.

 The regulatory authority has noticed a spike in suspected counterfeit versions of Ozempic, a GLP-1 agonist known as semaglutide, which is manufactured by Novo Nordisk and approved for managing type 2 diabetes. 

In South Africa, Ozempic is registered under two injectable pen formats: a lower dose pen (0.25mg or 0.5mg per dose) and a higher dose pen (1mg per dose).

 According to Sahpra, Ozempic is primarily prescribed for adults with poorly controlled type 2 diabetes as a supplement to diet and exercise to help reduce blood sugar levels.

Additionally, it is approved to lower the risk of severe cardiovascular events, including heart attacks and strokes, in adults with both type 2 diabetes and existing heart conditions.

 However, Sahpra emphasized that Ozempic is not approved in South Africa as a weight management solution.

Meanwhile, another GLP-1 product, Mounjaro (tirzepatide), developed by Eli Lilly and Company, is attracting attention locally.

While Mounjaro is approved for type 2 diabetes treatment and is sold in pre-filled pens with doses ranging from 2.5mg to 15mg, it has yet to be distributed in South Africa through official channels.

Like Ozempic, Mounjaro is also not registered for weight management within the country.

Sahpra noted that GLP-1 agonists are complex, sterile medications that require precise compounding. Unauthorized compounded GLP-1 products, often claiming to contain semaglutide, have not been reviewed by Sahpra to verify if they match the composition of the registered pharmaceutical ingredient.

As a result, these products may be substandard and pose health risks to users.

Sahpra stressed that any medication using an unregistered active ingredient violates South Africa’s Medicines and Related Substances Act and is thus illegal.

Sahpra urged the public to buy only Sahpra-registered GLP-1 products to ensure safety and efficacy. According to Section 29 of the Medicines and Related Substances Act, individuals found guilty of such offenses may face criminal charges and penalties.

Sahpra’s CEO, Boitumelo Semete-Makokotlela, highlighted the organization’s dedication to protecting public health in South Africa.

She added that Sahpra is actively monitoring online platforms and supply chains to detect and address unregistered, substandard, or falsified medications claiming to contain semaglutide.

Semete-Makokotlela encouraged the public to report any suspicious products that may be falsely advertised as Ozempic or Mounjaro, reinforcing Sahpra’s ongoing commitment to investigating violations of the country’s Medicines and Related Substances Act.

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